2018-27678. Determination of Regulatory Review Period for Purposes of Patent Extension; ABSORB GT1 BIORESORBABLE SCAFFOLD  

Document Information

Published:
12/21/2018
Department:
Health and Human Services Department
Agency:
Food and Drug Administration
EntryType:
Notice
Action:
Notice.
Document Number:
2018-27678
Dates:
Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 19, 2019. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 19, 2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Pages:
65680-65681 (2 pages)
Docket Numbers:
Docket Nos. FDA-2017-E-3592 and FDA-2017-E-3616
SectionNoes:
PDF File:
2018-27678.pdf